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Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00162851
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : July 25, 2007
Sponsor:
Collaborator:
Schering Nordiska AB
Information provided by:
Karolinska University Hospital

Brief Summary:
This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).

Condition or disease Intervention/treatment Phase
B-CLL Drug: alemtuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia
Study Start Date : April 2003
Actual Study Completion Date : July 2006






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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • B-CLL that has failed fludarabine

Exclusion Criteria:

  • Performance status grade 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162851


Locations
Sweden
Dept. of Hematology, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Karolinska University Hospital
Schering Nordiska AB
Investigators
Principal Investigator: Anders C Osterborg, Professor Dept. of Hematology, Karolinska University Hospital

ClinicalTrials.gov Identifier: NCT00162851     History of Changes
Other Study ID Numbers: CAM219
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: August 2005

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents